菜单

Pilot Production

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时间: 2018-09-17


Upstream Cell Culture

Ø GMP-certified cell banking.

Ø Two culture lines of 50L and 200L to produce gram to kilogram of proteins.

Ø Disposable system for convenient and time-saving.

Ø Advanced biochemical analysis system for real-time monitoring during cell culture.

Ø Stable and efficient culture control system to achieve high density and high yield.


Downstream Protein Purification

Ø Advanced chromatography systems and related equipments to achieve process customization from crude harvest to drug substance.

Ø  Disposable system for convenient and time-saving.

Ø  Efficient in-process control to ensure batch consistency.

Ø Virus inactivation and nanofiltration to ensure effective removal of the virus;


Aseptic Filling Production

Ø  Integrated procedure of sterilization, filling, freeze-drying systems for different dosage forms of biological drugs.

Ø Vial (liquid and freeze-dried), PFS and cartridge in GMP level.

Ø Periodic implementation of media fill test to validate the consecutive sterility of the whole filling system.


Supporting Facility

Ø Separated warehouses for raw materials, drug substance and drug products.

Ø Qualified QC testing procedure for raw material and excipient release, water and air system monstering, as well as microbiological attributes evaluation.


Pilot Production Platform

 

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